1. Field of the Invention
This invention relates to generally to sealants and adhesives, including the dressings and barriers that result from their use, for bio-medical applications. In particular, the invention relates to tissue sealants and adhesives used in Surgical, wound and trauma applications.
More specifically this invention discloses compositions and methods for Sealing or adhering tissues that are less toxic, less allergenic, less risk of infection, less risk of disease transmission by transmissible agents, more effective, less expensive and faster to biodegrade versus those of the prior art.
The need to repair damaged tissues is a common issue in medicine. The control of the loss of body fluids (i.e. bleeding, loss of CSF, etc.) and/or the ability to Seal and coat tissues following trauma, surgery or the progression of disease generally translates into decreased morbidity and mortality. Increased healing rates and decreased post operative complication rates are often additional great potential medical benefits. Historically, the use of sutures and biocompatible materials such as collagen, gelatin and oxidized cellulose has represented the standard of care. This approach relies on mechanical means (i.e. pressure), physical barriers, custom fitting and competent physiological processes to provide immediate success. In addition, the use of such biocompatible materials including Avitene®, Gelfoam®, and Surgicel® are often unreliable or even detrimental following closure of the tissue due to the propensity to migrate and the propensity of infection. The use of thrombin and fibrin glue products offer a greater degree of reliability, but the lack of mechanical strength, limited adhesion to moist tissues and the possibility of allergy limit their utility. Later advances in Surgical adhesives and sealants such as DuraSeal®, CoSeal® and BioGlue®, utilize cross-linked polymers, have increased the reliability of sealant and adhesive technology. However, the risk of allergy, the risk of BSE transmission, the toxicity at the tissue site, the lack of a convenient delivery device, extensive bio-resorption time, the low adhesive strength or reliance for specific applications, high swelling potential and the rates of infection associated with their use have proven problematic in varied degree for these new products when compared to traditional methods. In addition, in the case of the latter examples, acquisition costs represent a significant limiting factor in utilization. The present invention describes novel tissue sealant and adhesive methods and compositions that may be employed to design these products with improved mechanical strength and resilience, lower toxicity, lower swelling and lower infection rates. The invention may also be utilized to design sealants/adhesives that are more convenient, less variable in performance, less allergenic, less expensive, biodegrade in less time and possess less risk of disease by transmission by transmissible agents.
2. Related Art
A search of the prior art did not disclose any patents that read directly on the claims of the instant invention; however, the following references were considered related.
Journal: Braunwald et al. “Evaluation of crosslinked gelatin as a tissue adhesive and lenstatic agent: An experimental study”. Surgery—June 1966, pp. 1024-1030.
Journal: Bachet et al.: “Four-year clinical experience with the gelatin-resorcine-formol biological glue in acute aortic dissection.” J. Thorac. Cardioavasc. Surg. vol. 83 (1982), pp. 212-215.
Journal: Fabiani et al. “Use of Surgical Glue Without Replacement in the Treatment of Type A Aortic Dissection.” Supplement I Circulation vol. 80, No. 3 (September 1989), pp. 1264-1268.
Journal: Bachet et al.: “Surgery of type A acute aortic dissection with Gelatine-Resorcine-Formol biological glue: A twelve-year experience.” J. Cardiovasc. Surg. vol. 31 pp. 263-273 (August 1990).
Journal: Basu et al. “Comparative Study of Biological Glues: Cryoprecipitate Glue, Two-Component Fibrin Sealant, and “French” Glue”. Ann Thorac Surg 1995; 60:1255-1262.
Journal: Eddy et al, “The Effects of Bioglue™ Surgical Adhesive in the Surgical Repair of Aortic Dissection in Sheep”, European Association for Cardio-Thoracic Surgery, September 1998.
Journal: Suhji et al. “The use of gelatin-resorcin-formalin glue in acute aortic dissection type A”. European Journal of Cardio-thoracic Surgery 15 (1999) 564-570.
Journal: White et al. “The Use of a Novel Tissue Sealant as a Hemostatic Adjunct in Cardiac Surgery”. Heart Surgery Forum—March 2000, pp. 56-61.
Journal: Bingley et al. “Late Complications of Tissue Glues in Aortic Surgery”. Ann Thorac Surg 2000; 69:1764-1768.
U.S. Pat. No. 4,362,567, inventors Schwarz et al, issued December 1982.
U.S. Pat. No. 4,414,976, inventors Schwarz et al, issued November 1983.
U.S. Pat. No. 4,740,534, inventor Takehisa, issued April 1988.
U.S. Pat. No. 4,818,291, inventor Iwatsuki, issued April 1989.
U.S. Pat. No. 5,385,606, inventor Kowanko, issued Jan. 1995.
U.S. Pat. No. 5,213,580, inventors Slepian et al, issued May 1993.
U.S. Pat. No. 5,800,538, inventors Slepian et al, issued September 1998.
U.S. Pat. No. 6,372,229, inventors Ollerenshaw et al, issued April 2002.
Consequently, a need has been demonstrated for the invention which provides compositions and methods which provide solutions to the problematic attributes described in the Background and Related Art.